Tomomi Okubo1, Masanori Atsukawa2,3, Akihito Tsubota4, Hidenori Toyoda5, Noritomo Shimada6, Hiroshi Abe7, Keizo Kato7, Korenobu Hayama8, Taeang Arai1, Ai Nakagawa-Iwashita8, Norio Itokawa1, Chisa Kondo8, Chiaki Kawamoto1, Etsuko Iio9, Yasuhito Tanaka9, Takashi Kumada5, Katsuhiko Iwakiri8. 1. Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan. 2. Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan. momogachi@yahoo.co.jp. 3. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. momogachi@yahoo.co.jp. 4. Core Research Facilities for Basic Science, Research Center for Medical Sciences, Jikei University School of Medicine, 3-19-18 Nishishinbashi, Minato-ku, Tokyo, 105-8471, Japan. 5. Division of Gastroenterology, Department of Internal Medicine, Ogaki Municipal Hospital, 4-86 Minaminokawachou, 503-0864, Ogaki, Gifu, Japan. 6. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Otakanomori Hospital, 113 Toyoshiki, Kashiwa, Chiba, 277-0863, Japan. 7. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Shinmatsudo Central General Hospital, 1-380 Shinmatsudo, Matsudo, Chiba, 270-0034, Japan. 8. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. 9. Department of Virology and Liver Unit, Graduate School of Medical Sciences, Nagoya City University, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 487-0001, Japan.
Abstract
BACKGROUND/AIM: To evaluate the efficacy and safety of ledipasvir and sofosbuvir therapy for genotype 1b in chronic hepatitis C patients with chronic kidney disease (CKD) stage 3. METHODS: In a multicenter collaborative retrospective study, 706 patients who have received ledipasvir which is NS5A inhibitor, and sofosbuvir 400 mg which is NS5B nucleoside polymerase inhibitor daily for 12 weeks between September 2015 and January 2017 were subjected to this analysis. Virologic response and adverse events in patients with CKD stage 3 were compared with those in patients with CKD stages 1 and 2. RESULTS: The rates of sustained virologic response (SVR) were 97.0% in patients with CKD stage 1, 97.1% in patients with CKD stage 2, and 94.7% in patients with CKD stage 3, respectively. There were no significant differences in the SVR rates between CKD stages 1 and 2, and CKD stage 1 and stage 3. The incidence of adverse events over than grade 2 was 0% in patients with CKD stage 1, 0.5% in patients with CKD stage 2, and 3.0% in patients with CKD stage 3, respectively. For treatment and follow-up period, eGFR levels in the patients with CKD stage 3 were not worsened compared to those at baseline. CONCLUSION: This study suggested that the virologic response of ledipasvir and sofosbuvir in patients with CKD stage 3 was not inferior to those with CKD stages 1 and 2. In addition, administration of ledipasvir and sofosbuvir did not affect eGFR levels in the patients with CKD stage 3.
BACKGROUND/AIM: To evaluate the efficacy and safety of ledipasvir and sofosbuvir therapy for genotype 1b in chronic hepatitis Cpatients with chronic kidney disease (CKD) stage 3. METHODS: In a multicenter collaborative retrospective study, 706 patients who have received ledipasvir which is NS5A inhibitor, and sofosbuvir 400 mg which is NS5B nucleoside polymerase inhibitor daily for 12 weeks between September 2015 and January 2017 were subjected to this analysis. Virologic response and adverse events in patients with CKD stage 3 were compared with those in patients with CKD stages 1 and 2. RESULTS: The rates of sustained virologic response (SVR) were 97.0% in patients with CKD stage 1, 97.1% in patients with CKD stage 2, and 94.7% in patients with CKD stage 3, respectively. There were no significant differences in the SVR rates between CKD stages 1 and 2, and CKD stage 1 and stage 3. The incidence of adverse events over than grade 2 was 0% in patients with CKD stage 1, 0.5% in patients with CKD stage 2, and 3.0% in patients with CKD stage 3, respectively. For treatment and follow-up period, eGFR levels in the patients with CKD stage 3 were not worsened compared to those at baseline. CONCLUSION: This study suggested that the virologic response of ledipasvir and sofosbuvir in patients with CKD stage 3 was not inferior to those with CKD stages 1 and 2. In addition, administration of ledipasvir and sofosbuvir did not affect eGFR levels in the patients with CKD stage 3.
Authors: K Yamagata; K Ishida; T Sairenchi; H Takahashi; S Ohba; T Shiigai; M Narita; A Koyama Journal: Kidney Int Date: 2006-11-22 Impact factor: 10.612
Authors: M Mizokami; H Dvory-Sobol; N Izumi; S Nishiguchi; B Doehle; E S Svarovskaia; S De-Oertel; S Knox; D M Brainard; M D Miller; H Mo; N Sakamoto; T Takehara; M Omata Journal: J Viral Hepat Date: 2016-05-15 Impact factor: 3.728
Authors: Nezam Afdhal; K Rajender Reddy; David R Nelson; Eric Lawitz; Stuart C Gordon; Eugene Schiff; Ronald Nahass; Reem Ghalib; Norman Gitlin; Robert Herring; Jacob Lalezari; Ziad H Younes; Paul J Pockros; Adrian M Di Bisceglie; Sanjeev Arora; G Mani Subramanian; Yanni Zhu; Hadas Dvory-Sobol; Jenny C Yang; Phillip S Pang; William T Symonds; John G McHutchison; Andrew J Muir; Mark Sulkowski; Paul Kwo Journal: N Engl J Med Date: 2014-04-11 Impact factor: 91.245
Authors: Mark Sulkowski; Laura E Telep; Massimo Colombo; Francois Durand; K Rajender Reddy; Eric Lawitz; Marc Bourlière; Nelson Cheinquer; Stacey Scherbakovsky; Liyun Ni; Lindsey Force; Heribert Ramroth; Anuj Gaggar; Anand P Chokkalingam; Meghan E Sise Journal: Aliment Pharmacol Ther Date: 2022-03-02 Impact factor: 9.524